EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

Brief Title

EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)

Official Title

EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)

Brief Summary

      The main objective of this trial is to test the hypothesis that abatacept can reduce the
      progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism
      compared with patients treated with hydroxychloroquine.
    

Detailed Description

      The main objective of this trial is to test the hypothesis that abatacept can reduce the
      progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism
      compared with patients treated with hydroxychloroquine.
    

Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

The main objective of this trial is to test abatacept efficacy

Secondary Outcome

 Number of participants with treatment-related adverse events as asesed

Condition

Palindromic Rheumatism, Wrist

Intervention

Abatacept Injection

Study Arms / Comparison Groups

 abatacept
Description:  abatacept monotherapy (subcutaneous route).: 125 mg solution for injection in pre-filled syringe. In the first year (0-12 months) at a a dose of 125 mg per week (full dose) and in the second year (12-24 months) at a dose of 125 mg every other week (q2w) (optimized dose) injection) - 125 mg x week - subcutaneous use.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

98

Start Date

April 1, 2019

Completion Date

April 1, 2022

Primary Completion Date

April 1, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with PR according to Guerne and Weissman modified criteria (18) and with:

          -  Disease evolution > 3 months and < 24 months.

          -  ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid
             factor positivity (ELISA, nephelometry or chemiluminescence).

          -  Greater than 18 years of age.

        Exclusion Criteria:

          -  Persistent arthritis: (involvement in one or more joints > 1 week).

          -  Criteria of other rheumatic diseases (RA, SLE, etc.).

          -  Evidence of radiographic damage (join erosions).

          -  Absence of ACPA or RF.

          -  Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).

          -  Steroid treatment one month before study entry.

          -  Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide,
             sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.

          -  Pregnant women or who want to be pregnant during the study.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

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Administrative Informations


NCT ID

NCT03669367

Organization ID

PALABA 2017-004543-20


Responsible Party

Principal Investigator

Study Sponsor

Fundacion Clinic per a la Recerca Biomédica


Study Sponsor

, , 


Verification Date

July 2018